Medical Devices Promise Access, Accuracy

Medical device manufacturers in the US were following two big stories in June – and the results will begin to affect their business in 2013. In the last week of June, Congress voted to extend FDA user fees as part of the FDA Safety and Innovation Act. That same week, the US Supreme Court upheld the constitutionality of the Affordable Care Act, which includes a tax on medical devices.

Industry response to the FDA extension was generally favorable. The Advanced Medical Technology Association (AdvaMed) praised final Senate passage, saying the new law sets in place measures that should increase the efficiency and predictability of the FDA’s medical device review process.

The legislation includes a series of strong, measurable performance goals and additional funding that should help reverse the decline in performance that the FDA has experienced in recent years, said AdvaMed in a press release following the vote.

“This legislation will help improve an already robust review process by giving FDA the additional tools and resources it needs to improve its timeliness and consistency,” said Stephen J. Ubl, AdvaMed president and CEO. “That means more American patients will have access to safe and effective treatments and diagnostics sooner, which is the shared goal of both FDA and industry.”

Around the world, patients should see improved access as a result of projected growth in the global market. Medical device sales are expected to grow at a compound annual growth rate (CAGR) of 5 percent, eventually reaching $350 billion by 2016, according to a report published late last year by Market Publishers Ltd.

TechNavio’s new Global Medical Imaging Equipment Market analysis projects that this sector will reach $25.3 billion by 2015. Driven by technological advances and demand from emerging economies, the market is set to grow at 4 percent CAGR. Market constraints include a potential risk for cannibalization of medical imaging equipment resulting from technological advances, and a growing market concern for radiation, according to the report’s publisher.

In this issue of BioPhotonics, contributing editor Gary Boas takes a look at studies being done on an in vivo optical technique that may hold promise as a cheaper and less invasive way to screen for disease. In his article “In Vivo Studies Promise to Advance Diagnosis,” Boas talks with Vadim Backman, who, along with associates at Northwestern University in Evanston, Ill., is developing a technique called low-coherence enhanced backscattering (LEBS) spectroscopy. LEBS enables users to detect the ultrastructural properties of tissue, and Backman says the technique could have important implications for cancer management.

The researchers found that LEBS could detect the field effect even in histologically normal sites and, based on this, could predict the occurrence of cancer with remarkable accuracy. Beyond its interesting implications for basic science studies of the initial stages of cancer progression, it also suggests to researchers a “very big” clinical application: cancer screening. The article begins on page 22.

Also in this issue, recent advances allow superresolution microscopy to deliver on its promise of using focused light to provide glimpses of the inner workings of living organisms, resolving structures on the scale of tens of nanometers. In the article “Superresolution Microscopy Images Neurons on the Nanoscale,” beginning on page 29, author Dr. Brian Rankin of Mobius Photonics writes that “the past decade witnessed a renaissance in far-field light microscopy. After initial demonstrations proved that the diffraction-limited resolution barrier could be overcome by manipulating the molecular states of fluorophores used to label the sample, superresolution approaches and methods for their implementation multiplied.”

Finally, “Photocoagulation Refinements Are Decimating Birthmarks (but Improving Birth Outcomes),” as Lynn Savage reports in his article beginning on page 34. Beyond precision cutting, lasers also bring heat. Researchers are finding that aiming a properly chosen laser onto a blood vessel or other tissue section adds enough thermal energy that the tissue’s properties alter. When heat is applied to a blood vessel, the vein or artery deforms, or even withers away if enough energy is used, and this can be put to good use in medicine.